SDIX to Help Egg Producers Meet New FDA Regulatory Challenge

NEWARK, DE – SDIX (Strategic Diagnostics Inc., d/b/a SDIX, Nasdaq: SDIX), a leading provider of biotechnology-based products and services for a broad range of life science, biotechnology, diagnostic, and food safety applications, today commercially launched the RapidChek SELECT Salmonella Enteritidis testing system.  The new system was designed in coordination with leading experts in egg safety.  It is applicable to both egg and poultry industries. However, it will specifically help U.S. commercial egg producers comply with the new Food and Drug Administration (FDA) regulation that requires them to test poultry houses and eggs for Salmonella Enteritidis (SE).

The new FDA rule became effective July 9, 2010 for commercial egg producers with over 50,000 laying hens and becomes effective July 9, 2012 for egg producers with between 3,000 and 49,999 laying hens.  The new Rule will affect approximately 4,000 commercial egg producers in the USA. It is estimated that 47 billion eggs are consumed annually in the U.S. and according to reports from the USDA and FDA, there are 2.3 million eggs annually contaminated with Salmonella Enteritidis.

The RapidChek SELECT system is an easy, accurate, flexible, and rapid food pathogen detection technology. It combines the simplicity of advanced immuno-based detection system with SDIX’s proprietary, patented phage-based enrichment media to significantly enhance both the specificity and sensitivity of the test and to enable improved pathogen detection. The system is designed to:

• Make it easier to comply with the new FDA Rule – easy to learn and use, fast results, robust detection for a better overall picture of hen house cleanliness, layer health, and egg safety
• Help minimize disruption to daily operations – high accuracy virtually eliminates false positives. Ease of use and speed to results reduce workflow impacts
• Help minimize costs – reduces training, labor, operating costs.  Reduced false positives decreases unneeded egg testing costs

The RapidChek SELECT Salmonella Enteritidis system has been evaluated at several large egg producers and independent testing laboratories during development to ensure it meets customer needs. Significant validation work has already begun and the Company expects to submit the system to the FDA, AOAC RI, and NPIP for approval and certification during the second half of 2010.

The new testing system is comprised of the RapidChek SELECT Salmonella Enteritidis detection system for screening environmental drag swags or pooled eggs and the RapidChek CONFIRM Salmonella Enteritidis immunomagnetic separation system for confirmation.

Tim Lawruk, SDIX Food Safety Marketing Manager, said “Commercial egg producers are faced with significant technical and business challenges as they strive to meet the FDA’s new requirements for both poultry house and egg testing. The new RapidChek SELECT Salmonella Enteritidis testing system is specifically designed to help them meet those challenges and provides SDIX with an opportunity to leverage its expertise in pathogen detection.  The system offers competitive advantages that include ease of use, low start-up and operating costs, and a faster time-to-result than other methods.  Moreover, the new system’s high accuracy virtually eliminates false positives and the harmful business impacts they can have. It enables egg producers to focus more on their core business of providing safe, high-quality eggs.”